Study of [68Ga]FAPI-46 PET in Patients with Pancreatic Ductal Carcinoma

Phase 2

Active, not recruiting

• Conditions: PDAC - Pancreatic Ductal Adenocarcinoma; FAP
• Interventions: Drug: [68Ga]FAPI-46

• Registration Number: NCT05262855
• Lead Sponsor: SOFIE

Brief Summary

This is a prospective, multi-center, single arm, open label, non-randomized study to evaluate the ability of \[68Ga\]FAPI-46 to detect FAP expressing cells in patients with resectable or borderline resectable PDAC. The \[68Ga\]FAPI-46 PET scans will be acquired after initial staging using institutional standard methods. If the participant is prescribed neoadjuvant therapy, a second \[68Ga\]FAPI-46 PET scan will be performed within 21 days prior to planned surgical resection. This will be followed by histopathology and IHC analyses and comparison to resected PDAC tumor specimens.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-10
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-03-02
• Study Start: 2022-05-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-05-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Pathologically confirmed pancreatic ductal adenocarcinoma
2. Treatment-naïve
3. Staged as resectable or borderline-resectable
4. Planned to undergo surgical resection or to receive neoadjuvant therapy (i.e., chemotherapy, radiation therapy, or combination) and subsequent possible surgical resection
5. Anatomic imaging (e.g., CT, MRI) obtained within ≤ 28 days of consent
6. Age ≥ 18 years
7. Completed informed consent as determined per the IRB of record

Exclusion Criteria

1. Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
2. Declining to use effective contraceptive methods during the study (for individuals of child-producing potential)
3. Need for emergent surgery that would be delayed by participation
4. Bacterial, viral, or fungal infections requiring systemic therapy
5. Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator, physician of record and/or Sofie could compromise patient safety and/or protocol objectives.
6. Known diagnosis of autoimmune disorders
7. Patients receiving any other investigational agent within the past 28 days
8. Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the [68Ga]FAPI-46 injection.
9. Known hypersensitivity to any excipients used in [68Ga]FAPI-46:

trace amounts of sodium acetate sodium ascorbate and/or hydrochloric acid

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-FAPI-46 PET/CT	[68Ga]FAPI-46	Patients receive \[68Ga\]FAPI-46 intravenously followed by PET/CT 15-25 minutes later

Primary Outcome Measures

Name	Time	Method
Performance [sensitivity, specificity, accuracy] of [68Ga]FAPI-46 PET imaging to detect FAP-expressing cells, using histopathology as truth standard.	Through study completion, 2 years

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Up to 24 hours post injection with [68Ga]FAPI-46
Positive and negative predictive values, as well as accuracy of [68Ga]FAPI-46 PET images, to detect FAP-expressing cells using histopathology as truth standard.	Through study completion, 2 years
Histopathology with FAP staining on FAP IHC assay.	Through study completion, 2 years
[68Ga]FAPI-46 accumulation observed in local and metastatic disease compared to radiological (i.e. CT, MR) and/or 18F-FDG PET.	Through study completion, 2 years
[68Ga]FAPI-46 accumulation observed by (PET)/ (CT) pre and post in patients undergoing Neoadjuvant treatment.	Through study completion for patient undergoing Neoadjuvant treatment, 2 years

Trial Locations

Locations (4)

University of California Los Angeles (UCLA) Health; 🇺🇸 Los Angeles, California, United States

BAMF Health; 🇺🇸 Grand Rapids, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

NYU Langone Health; 🇺🇸 New York, New York, United States